Method for creating and using registry of clinical trial participants

ABSTRACT

A method of screening participants for a clinical trial by obtaining identifying information chosen from a biometric sample, personal information, physical attributes, and combinations thereof from a prospective participant, optionally generating a unique identifier code, populating a database server with the unique identifier code and participant information and storing the information on non-transitory computer readable media, screening the participant for a clinical trial based on either the unique identifier code and/or participant information and searching for a match with existing participant information in the database server and a plurality of outside databases to determine protocol violations, and determining eligibility of the participant for the clinical trial and preventing the protocol violations. A system for screening participants for a clinical trial and preventing future violations while currently enrolled in a clinical trial.

BACKGROUND OF THE INVENTION 1. Technical Field

The present invention relates to registries of clinical trialparticipants. More specifically, the present invention relates tomethods of preventing participants from enrolling in multiple clinicaltrials simultaneously, and to perform other types of checks onparticipants, across all types of drug and device trials in all phasesof clinical research.

2. Background Art

There are many research studies conducted by various institutions andcompanies that make up “clinical trials”. These clinical trials aregenerally used to verify the safety and efficacy of pharmaceuticals,biopharmaceuticals, and medical devices for the FDA. There are manydifferent types of clinical trials, including treatment trials,prevention trials, diagnostic trials, screening trials, and quality oflife trials.

The general public can enroll in clinical trials if they meet thecriteria of the particular trial, such as having or not having a certainmedical condition, currently taking a particular type of medicine, orhaving certain health characteristics. Clinical trials can be beneficialto many people who have exhausted currently approved treatments fortheir conditions since they allow such people to seek experimentalprocedures in order to improve their quality of life. People enrolled inclinical trials must also be aware of their risks, such as side effectsand adverse reactions, or the fact that the treatment might not provideany results. There is a lot of motivation for people, especially in badeconomic times, to join clinical trials because they are compensatedmonetarily to receive medical evaluation and care as well as freemedication. However, some people try to enroll in clinical trials morethan once providing false information, or attempt to screen and enrollin several clinical trials at the same time. This not only can bedangerous to the person's health, but it can result in unreliable datafor the organization conducting the trial.

There are several methods currently used for maintaining registries forclinical trials. For example, US Patent Application Publication No.2008/0052125 to Bennett, et al. discloses a method for maintaining thecontact information of an enrollee in a clinical study while maintainingthe anonymity of the enrollee from the clinical study sponsor. Themethod includes: (1) obtaining contact information for the enrollee inthe clinical study; (2) entering the contact information into adatabase; (3) using a contact cascade on a scheduled, periodic basis tocontact the enrollee using the contact information from the database toensure that the contact information is correct; and (4) updating thecontact information if a contact is made with the enrollee and thecontact information needs to be updated to be accurate. While thismethod keeps track of contact information, it cannot easily be used toprevent multiple enrollments under false information.

US Patent Application Publication No. 2008/0033658 to Dalton, et al.discloses computers, computer program products, and methods foridentifying a plurality of subjects for a clinical trial. A candidateset of molecular profiles in a stored plurality of molecular profilesare identified. Each such profile has measurements for a discriminatingset of cellular constituents that match the measurements ofcorresponding cellular constituents in a responder set of biologicalsamples, thereby identifying the plurality of subjects for the trialfrom those subjects from which the candidate set of molecular profileswere derived. Each respective molecular profile in the stored pluralityof profiles has measurements of a plurality of cellular constituentsfrom a respective biological sample in a plurality of samples obtainedfrom a first plurality of subjects. The discriminating set of cellularconstituents is identified from those cellular constituents in theplurality of cellular constituents whose measurement valuesdiscriminates between the responder and non-responder sets of biologicalsamples. This method is used to select specific candidates for aparticular trial based on their biological samples, but is not used toprevent multiple enrollments.

US Patent Application Publication No. 2010/0023870 to Baker discloses anapparatus and methods that implement a computer-based system andprocedure for the efficient and effective operation of one or moreclinical trials using an institutional review board (IRB). The variousmethods are deployed against the backdrop of an Internet-based SoftwareAs A Service (SaaS) platform, allowing access to the system by allrelevant participants. Each authorized participant in the clinical trialcan have a customized and customizable view of the clinical trial andinteract with the other participants electronically. The variousdocuments required for completion of the clinical trial or study, aswell as the various compliance documents needed to satisfy regulatoryagencies are all available for review via the Internet. By utilizing themethods and system of the present invention, greater protection isoffered for the human subjects of the clinical trials. Further, thesponsors, investigators, and the study participants can experienceincreased productivity. Finally, FDA mandated information can be morereadily tracked and, accordingly, compliance with FDA guidelines can beenhanced. This method is directed to controlling information pertainingto the trials, but does not prevent multiple enrollments.

US Patent Application Publication Nos. 2005/0159654 and 2003/0130871 toRao, et al. disclose a system and method for selecting prospectivepatients for a clinical trial. In various embodiments, a clinical trialsbrokerage is configured to receive requests from drug companies forlists of persons meeting specified criteria for clinical trials. Patientrecords are retrieved from a structured computerized patient record(CPR) data warehouse populated with comprehensive patient informationmined from unstructured hospital records. A list of persons for whomconsent was obtained can be outputted and forwarded to the entityinterested in performing the clinical trial and which requested thelist. Anonymity of a patient can be maintained until the patientprovides consent to participate in the clinical trial. This method alsodoes not provide any secure means of preventing multiple enrollments intrials.

US Patent Application Publication No. 2004/0006553 to de Vries, et al.discloses a method of conducting clinical trials over a network (e.g.the Internet or telephone grid). All trial participants and all trialinvestigators are asked to provide a baseline biometric reading,consisting of one or more of voiceprint, fingerprint, iris scan,electronic signature or other biometric modality, along with one or moreidentifiers such as their name, a user name and password combination,etc. The provided biometric information and identifiers are thenpermanently recorded into the biometric consent database. This biometricconsent database is then used to obtain informed consent verified withbiometric authentication from the enrolled trial participants andinvestigators. A unique code can be assigned to each trial participant.This method does not provide any way to maintain the integrity of atrial and prevent multiple enrollments or protocol violations.

US Patent Application Publication No. 2010/0185462 to Lungescu, et al.discloses Clinical RSVP, a web-based subject registry used byinvestigators to make better-informed enrollment decisions for clinicalresearch studies. Research sites can report dose dates of subjects forthe purpose of identifying ineligible subjects and ensuring against dualenrollment. Fingerprint biometric identification (or other biometricinformation, such as iris, retinal, or facial recognition or DNA) can beused along with other identifying information such as initials, birthdate, sex, and last four digits of a social security or tax ID number.The subject is fingerprinted when screened for the trial, thefingerprint is then scanned, and a code is generated and stored in adatabase along with the other identifiers. The registry is searchablefor a subject's information. Clinical RSVP is used for phase I trials.There are several disadvantages of using biometric fingerprinttechnology with this system. Firstly, the technology does not functionaccurately in a significant percentage of cases. Many senior subjects orlaborers are especially prone to problems with this technology as thesystem has difficulty reading the fingerprints. To supply all researchsites in the country is not only expensive, but remains impractical andproblematic as well. There are hardware and software installationsrequired with this technology, which adds cost and time. When problemsare encountered with fingerprint scanning, it slows down the entirescreening process. Many potential research subjects have concerns aboutleaving biometric information with the research site. Clinical RSVPremains focused on early phase studies as providing fingerprint scannersto every research site across the country would be too expensive andtime consuming. Clinical RSVP therefore does not have penetration tolater phase studies, and does not prevent other key protocol violations,and many subjects are known to cross between phase 1 studies and laterphase studies.

While many of the above described systems can generate databases ofprospective participants in clinical trials, there is no unified systemto stop research subjects from enrolling in more than one clinical trialat a time across all phases of clinical research and all therapeuticareas in both device and/or drug clinical trials, or waiting themandated waiting time or washout period between clinical trials,exclusionary criteria that are listed in most drug and device clinicaltrials. There are also current problems prohibiting an effectiveclinical trial registration because of the lack of a system and protocolthat respects patient privacy while handling a wide array of patientinformation. Furthermore, there is no system that has the ability toanalyze multiple databases in which patient data can be found in orderto provide a thorough screen for a clinical trial to prevent protocolviolations. There currently exists no synthesized and query-able datasetthat could perform the operations needed for a complete search ofrelevant clinical trial data. Even complete electronic health/medicalrecords do not contain all of the information needed to determine if apatient qualifies for a clinical trial. It is not technically feasibleto search all existing outside databases ‘on-demand’ when evaluatingwhether or not they qualify for a study. Also, such a method could notbe performed by humans. The study participation history and personalinformation as well as biometric information cannot be shared acrossmedical offices, across research sites, research units, CROs, nor withthe sponsor of the clinical trial. Therefore, there remains the need foran improved screening system to prevent duplicate enrollment andprotocol violations for clinical trials to reduce costs of clinicalresearch and improve clinical research safety and data quality with theability to search a plurality of databases containing patientinformation as well as create a de-identified method to check studyparticipation history across multiple sites and companies.

SUMMARY OF THE INVENTION

The present invention provides for a method of screening participantsfor a clinical trial by obtaining identifying information chosen from abiometric sample, personal information, physical attributes, andcombinations thereof from a prospective participant, populating adatabase server with the participant information and storing theinformation on non-transitory computer readable media, screening theparticipant for a clinical trial based on the participant informationand searching for a match with existing participant information in thedatabase server and a plurality of outside databases to determineprotocol violations, and determining eligibility of the participant forthe clinical trial and preventing the protocol violations.

The present invention also provides for a system for screeningparticipants for a clinical trial, including an electronic databaseserver in electronic communication with a server instance for collectingparticipant information on non-transitory computer readable media, saidserver instance including a screening mechanism for determiningeligibility of the participant for the clinical trial and preventingprotocol violations and being in electronic communication with aplurality of outside databases.

DESCRIPTION OF THE DRAWINGS

Other advantages of the present invention are readily appreciated as thesame becomes better understood by reference to the following detaileddescription when considered in connection with the accompanying drawingswherein:

FIG. 1A is a flow chart of the general method of the present invention,and FIG. 1B is a flow chart of more specific steps of the method;

FIG. 2 is a flow chart of steps of the method of checking participantcredentials;

FIG. 3 is a flow chart of further steps of the method of checkingparticipant credentials;

FIG. 4 is a flow chart of further steps of the method of checkingparticipant credentials;

FIG. 5 is a depiction of the flow of information and components in thesystem of the present invention;

FIG. 6 is a flow chart of information between a database server andinstance server; and

FIG. 7 is a flow chart of processes in the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention generally relates to methods of screeningprospective patients and preventing multiple enrollments by searchingmultiple databases for participant information. The present inventionalso relates to the use of biometric identification techniques, such asDNA identification, to allow for accurate screening for clinical trialsin order to improve the reliability of data obtained while maintainingthe confidentiality of the prospective and actual participants. Thepresent invention also relates to determining eligibility of prospectiveparticipants in a trial and preventing protocol violations that canpossibly affect safety and data quality of a clinical trial. The presentinvention is particularly suited to prevent persons from enrolling inmultiple or repeated clinical trials under false identities forcollecting remuneration.

Most generally, the present invention provides for a system 10 forscreening participants for a clinical trial, including preferably aunique identifier code generator 12, an electronic database server 14for storing unique identifier codes generated (if generated) andparticipant information on non-transitory computer readable media, and ascreening mechanism 16 for determining eligibility of the participantfor the clinical trial and preventing protocol violations. The uniqueidentifier code generator 12 is an optional component. The screeningmechanism 16 is in electronic communication with multiple outsidedatabase servers of patient information 18. The system 10 preventsduplicate enrollment and protocol violations but also can obtain statusupdates by communicating to IVRS/IWRS and multiple databases. However,the prevention of protocol violations is within the system 10 asclinical trial sites enter each prospective participant in the registry.This system 10 is further described in the method below and shown inFIG. 5 , FIG. 6 , and FIG. 7 .

The present invention also provides for a method of screeningparticipants for a clinical trial by obtaining identifying informationchosen from a biometric sample, personal information, physicalattributes, and combinations thereof from a prospective participant,optionally generating a unique identifier code, populating a databaseserver with the unique identifier code if generated and participantinformation and storing the database on non-transitory computer readablemedia, screening the participant for a clinical trial based on theunique identifier code if generated and participant information andsearching for a match with existing participant data in a plurality ofdatabases to determine protocol violations, and determining eligibilityof the participant for the clinical trial and preventing the protocolviolations. The method has the technical effect of helping determinewhich prospective participants are eligible to participate in theclinical trial in order to populate the clinical trial.

The method, generally shown in FIGS. 1A and in more detail in FIG. 1Band FIG. 7 , can first include the steps of obtaining consent orauthorization of the prospective participant, obtaining identifyinginformation from the prospective participant, optionally generating aunique identifier code for the prospective participant with the uniqueidentifier code generator 12, populating a database server 14 with theunique identifier code and participant information and storing theinformation on computer readable media, and screening the participantfor a clinical trial based on the (optional) unique identifier code andparticipant information with the screening mechanism 16 and searchingfor a match with participant data on the database server 14 and multipleoutside databases 18.

The identifying information from the prospective participant can bebiometric data or information, or a combination thereof. When aprospective participant applies to be in a clinical trial, consent isobtained to collect and use personal information and/or biometricinformation to be screened for the clinical trial. A biometric samplecan be taken from them to add to/compare with other samples in thedatabases. The biometric sample can be a tissue sample that can beanalyzed for DNA, RNA, or any other unique biological identifier.Because everyone has a unique DNA profile, this can be used to identifyparticipants with greater accuracy than by taking their name andgovernment assigned information. The sample can be hair or a body fluidsuch as saliva, urine, blood, or plasma. The sample can also be obtainedby a cheek swab. The biometric sample can also be an iris scan, a voicerecording, photograph or picture for face recognition, fingerprints,palm vein scans, or any other type of biometric information. Anycombination of the above biometric samples can be used. A biometricsample obtaining mechanism 24 can be used to obtain any of the biometricsamples listed above (such as, but not limited to, a fingerprintscanner, a camera, an iris scanner, a voice recorder, a video camera, orany other type of scanner) and can be in electronic communication withthe unique identifier code generator 12 and the electronic databaseserver 14.

A unique identifier code (UIC) associated with the prospective clinicaltrial participant can optionally be generated based on the personaldemographic information and also associated with the biometric sampleand be stored in the database server 14. The UIC provides ade-identifying method of identifying a participant. The UIC is areproducible algorithm that is a 64 alphanumeric code that is based onthe personal information. When the participant presents to the researchfacility again, the UIC is detected as an identical match within thedatabase server and the research site would have the dates of hiseligibility. If the participant is not beyond the allotted or specifiedtime window of study completion or termination, then that participant isnot eligible to participate in the study. If it is more than the neededtime frame, the participant can enter the next clinical trial providedthey meet all of the study specific eligibility criteria.

The unique identifier code can use a subset of personal demographicinformation (i.e. personal information), such as, but not limited to,first name, middle name, last name, date of birth, gender, andgovernment issued identification (social security number, tax ID number,driver's license number, passport number, or any other form ofgovernment issued ID), or combinations thereof and/or a subset ofpersonal physical attributes and characteristics (i.e. physicalattributes), such as, but not limited to, height, weight, hair color,facial recognition, eye color, or combinations thereof. Any otherpersonal information can also be used. In other words, a biometricsample does not need to be taken for the identifying information, andinstead personal information and/or physical attributes are obtainedfrom the participant in order to generate the unique identifier code. Itshould be understood that any combination of these identifyinginformation can be used. Using multiple types of information can ensurethe prevention or duplicate or multiple simultaneous enrollment inclinical trials.

Social security numbers and tax ID numbers can also be obtained, enteredinto the database server 14, and checked instantaneously at thescreening to assure that subjects are responsible for the taxes incurredfor stipend disbursements and/or further confirm the participant's trueidentity. Third party software can be used to validate governmentidentification, and can also be used to check criminal backgrounds/sexoffender status in order to prevent potentially dangerous individualsfrom being confined with other inpatients during a study. The uniqueidentifier code generated protects the participants' true identities andis HIPAA and GCP compliant.

An IVRS (interactive voice response system) or an IWRS (interactive webresponse system) can be used (or any other suitable system that collectsidentifiers in clinical research, such as IXRS® (Almac)) that usesinitials and identifiers to detect duplicate enrollment or protocolviolations in order to collect any prospective participant information.Any information collection methods in the process can be web-based, aswell as any forms or reports submitted as described herein. Furthermore,commercially available ID scanners can be used to rapidly and accuratelyassess the validity of the subject's ID and can import that data to thesystems database.

The database server 14 and its relation to other parts of the system 10can be seen in FIGS. 6 and 7 . The overall system infrastructure isshown in FIG. 6 . A server instance 26 is separate from the databaseserver 14 and generally controls the flow of information in the system10. It is best practice for database-dependent applications to have thedatabase server separate from the main application server because if anytechnical or security issue should comprise the main application server,the database server remains intact. The server instance 26 can be avirtual server such as those run through Amazon Web Services (AWS),Microsoft Azure, or a custom physical server. The server instance 26 isable to run MVC (model, view, controller) application frameworks such as.NET MVC, Ruby on Rails, Django, Flask, or other suitable programs. Mostpreferably, the server instance 26 uses Elastic Compute Cloud (EC2)offered through AWS, running the Flask framework. The server instance 26includes a controller 28 to direct the flow of information in the system10. The controller 28 processes incoming user requests, and receives andsends information to the database server 14 such as patient information,screen information, study information, and rules. The controller 28sends information to various processes such as generating a UIC,querying external databases, report generating, and generating alerts.The controller 28 also sends information to a template 30 that cangenerate various user-friendly screens to enter information for patientregistration, search pages, administrative views for adding or changingsettings, and inventories.

The database server 14 can be any SQL database or data store thatsupports encryption such as, but not limited to, MSSQL, MySQL,PostgresSQL, or MongoDB. Preferably, the database server 14 is aRelation Database Service (RDS) offered through AWS running aPostgresSQL server.

The information in the database server 14 through the use of anappropriate template 30 can be viewed on any type of screen (computermonitor, smart phone screen, tablet, or any other wireless device). Thedatabase server 14 can be an existing database that can be accessed byany organization or one created by the particular organization for theirparticular clinical trial or set of clinical trials. Access to thedatabase server 14 can be via a remote connection (wireless, Bluetooth)or a wired connection. Fields of the database server 14 are populatedwith the participant's biometric identifying information (and uniqueidentifier code if generated) along with any other relevant informationabout the participant, such as, but not limited to, their history ofparticipation in other clinical trials, status of current enrollment orprospective enrollment in clinical trials, the study start and end datesof the other clinical trials, the sponsor and sponsor information forthe other clinical trials, and the trial site, contact person, protocolidentifier, study number, and combinations thereof. The database server14 is secure, and while a participant can delete their personalinformation from the database server 14, the database server 14 storesthe unique identifier code for the screening step.

After the information for the prospective participant is added to thedatabase server 14, it can be compared with existing information in thedatabase server 14 in the screening step with the screening mechanism 16(controlled by the server instance 26). In other words, a search for amatch with existing participant information is performed, as detailedfurther in Example 1, based on the unique identifier code and/or theidentifying information obtained from the prospective participant. If anindividual is found with matching unique identifier codes or informationto existing information, an alert can be made that the prospectiveparticipant is potentially enrolling in the trial multiple times,enrolling in multiple trials at once, or enrolling in a trial soonerthan the specified mandatory washout period between clinical trials.

Information can also be compared with any other outside existingdatabases 18 and/or systems that collect or maintain research subjectinformation and/or screening and enrollment information for clinicaltrials, such as, but not limited to IVRS/IWRS databases,screening/dosing logs, any clinical trial management system (CTMS) ofany kind, databanks that have research subject information, databanksthat have information regarding drug/medication use, blood productdonation databases of any kind, sperm banks, or any human by-productdatabase. Therefore, the system 10 of the present invention cancommunicate electronically with other outside existing databases ofclinical trial participants or other medical-related databases tocross-reference participant information. This also ensures that protocolviolations do not take place. The system can look at non-researchpatient bases and populations as well so that past non-trial activitycan be used to exclude patients from a study or exclude researchsubjects from blood-product donation, sperm donation, etc.

In order to search and compare information in outside databases 18,queries are performed on each outside database 18 individually.Depending on the database, there can be different search requirementsand parameters. A custom communication protocol/standard can be used.The server instance 26 takes parts of the prospective participant'sinformation and maps them appropriately so they can be used as a search.Any dataset containing matches on the given prospective participantreturns requested data so it can be added to the main database server14. Since different software uses different data structures andparameters, the data mapping stage is tedious but once setup enablesquick and secure access. Overall, the server instance 26 is able topull, access, and unify all the data in the database server 14 and theexisting outside databases 18 in order to screen the prospectiveparticipant. As shown in FIG. 7 , the server instance 26 pulls all datain the electronic database server 14 as well as the outside databases 18and unifies the data in order to screen the data.

Based on the prospective participant's information and comparing withother information in the screening step, it can also be determined ifthe prospective participant is violating protocol of the clinical trialbecause of past study screening and enrollment, past investigationalcompound exposure, or past study history. More specifically, protocolviolations (or deviations) can be searched for in both the databaseserver 14 of the present invention and also in a plurality of existingoutside databases 18 (especially existing clinical trial databases) thatthe database of the present invention is in communication with using anyof the identifying information obtained above for the participant. Inother words, the searching mechanism can search within any outsidedatabase 18 that is in communication with that of the present inventionin order to find the protocol violations. These violations can includeif the violation is due to the prospective participant currently beingin-screening or enrolled at the same or another research site, if theyare violating the required number of half-lives since the last researchtrial, if they are violating the washout period in between trials, ifthey are violating a biologic modifier washout period, if they have beenpreviously exposed to the same investigational compound if exclusionaryper the protocol, if they have exceeded the maximum number of clinicaltrials per period of time, if they already were a screen failure for thesame trial if exclusionary, if they have a blood draw violation (i.e.amount of mL/cc or volume or date of last blood draw is in violation ofprotocol), if they have a plasma draw violation (i.e. amount of mL/cc orvolume or date of last plasma draw is in violation of protocol), and iftheir last visit is in violation of protocol. If any one or more ofthese protocol violations are found, the prospective participant can bedetermined to be ineligible for the clinical trial. In other words, theinformation can be used to prevent clinical trial protocol violationsand potential safety issues based upon a prospective participant's priorscreening or enrollment at various other clinical trials. Unlike othermethods of screening candidates, the present invention is able todetermine violations for any and all of the above reasons, not just asingle reason and covers all therapeutic areas and all phases ofclinical research by searching through many existing clinical trialdatabases and other databases that include participant information.

Any additional information can be obtained by the prospectiveparticipant in order to search for the protocol violations, such as, butnot limited to, past drugs used, past doses of drugs, dates of drug use,dates of visiting a clinical trial research site, or drug half-lives.The searching mechanism can also include requirements for the particularclinical trial being screened (i.e. what drugs would react adverselywith the current trial, time periods required to be free of certaindrugs, etc.) to compare with any information found regarding theprospective participant in order to determine whether a protocolviolation exists.

In the example of blood draw and plasma draw violations, the system 10of the present invention can be in electronic communication with blooddonation center (blood bank) and plasma donation center databases tosearch for violations. Typically research subjects are not allowed todonate plasma or blood products to blood banks. When usinginvestigational compounds, this can be dangerous as recipients of theseblood products and plasma can be exposed to investigational compounds.The system 10 of the present invention can link with blood donation andplasma donation centers in order to notify them of their study statusand washout times with all the same alerts as above. The system 10 ofthe present invention and the outside databases 18 of the blood andplasma donation centers can communicate electronically to one another tonotify blood and plasma donation centers of donation from researchsubjects or to prevent research subjects from participating in trial ifthey recently donated blood, blood products, or plasma and the amountdonated. Communication with the blood and plasma donation centers can beperformed at any point in the participant's involvement with a study,and not just during screening.

The database server 14 can detect matching information within seconds toidentify potential conflicts and send notifications to relevantindividuals by electronic methods (i.e. email, SMS, text, phone) orwritten methods. If a subject is a “Verification Failure”, the researchsite coordinator is immediately aware and can inform the subject. If anyone or all of the protocol violations are found, the research site canbe notified immediately. If there is a conflict whereby the subjectstates that this information is not correct, then the researchcoordinator can contact higher administration for immediate explorationand resolution of the problem by contacting the prior research site. Anyverified clinical trial administration and research site and clinicaltrial sponsor can be notified of the results of the database comparison.Furthermore, any research site and verified clinical trialadministration can be notified if screened, enrolled, or subjects inwashout periods attempt to violate protocol at other sites. Also, anyresearch site, verified clinical trial administration, or administrationof other databases of medical information (i.e. blood bank or sperm bankadministration) can be notified if a subject that is in screening orrandomized at a research site/unit has attempted to screen or randomizeelsewhere or is attempting to donate blood products, sperm, or any otherphysiologic product. The system also has the ability for anyadministrator to obtain notifications and act on them by clicking a linkto change the subject's status at their site or send notification toadministrators of the system to update the status.

The administration can fully review the information provided by theprospective participant to determine if they should be included in theclinical trial. By catching potential multiple enrollees or unqualifiedenrollees, the organization can prevent repeated and false data andother problems from occurring during the clinical trial. This can savethe pharmaceutical sponsor money by preventing costly screenings andclinical trial enrollment of poor quality subjects. Furthermore, aninvestigational compound may falsely seem to have adverse events orserious adverse events that might not be caused by the investigationalproduct if taken at the correct dose or not combined with ourinvestigational agents. Moreover, the investigational agent may appearto have a falsely elevated placebo rate if poor quality subjects join atrial for the wrong reasons and never take the product but provide falseanswers. This could result in making the agent appear not be efficaciousor safe resulting in significant loss of IP and money.

Any verification failures can also generate a blacklist or hold listwith prospective participant information that prevents poor qualitysubjects with certain infectious diseases, medical conditions, orbehaviors to be excluded from research studies, blood donations, plasmadonations, or sperm donations. Such blacklists or hold lists can becommunicated electronically to other clinical study databases, blooddonation centers, plasma donation centers, and sperm donation centers.

Otherwise, if no matching information is found, the participant can beentered into the clinical trial. If there is no conflict, the researchcoordinator can obtain a “Verification Success” certificate generated bythe system and place this in the source document.

The sponsor of the clinical trial can see screening, enrollment, andother completion activity logs in real time.

The system 10 can include a visit reminder feature to send SMS textphone calls, and/or email to remind subjects of their upcoming visits toreduce out of window visits (late appointments) and subsequent protocolviolations. Every time that a reminder is sent out, this can includeinstructions for their upcoming visit. This can help ensure that thesubject is properly prepared for their upcoming visit.

Reports of any of the information in the database server 14 can becreated as desired with a report generating mechanism 20. For example,reports of prospective participants who attempt to enroll in multipleclinical trials at once or for the same trial twice can be generated.Reports can be provided to the clinical trial sponsor, CRO (contractresearch organization), research site, or any other individuals ororganizations. Reports regarding attempted simultaneous enrollments areimportant to know in an effort to gauge the problem within the industryas well as to let the sponsor and CRO know the value of the service.Generation of reports provides a technical effect whether the reportsare printed or electronic.

Any prospective participant or participant that is enrolled in aclinical trial can opt to receive and be contacted directly in ade-identified manner about various clinical trial-related communicationsvia email, mail, text, SMS, voice call, voicemail, or any othercommunication method with a communication mechanism 22. Thesecommunications can include, but are not limited to, safetycommunications, new study related instructions, IRB approved recruitmentfor new studies, data or study results (general or specific) withregards to dose and efficacy of the investigational treatment,engagement of the participant, or combinations thereof.

In performing the method, a protocol submission form (PSF) can be used.The PSF can be manual or online (web-based). A trial can be built withthe database. The PSF can obtain information such as, but not limitedto, protocol name and/or number, compound, half-lives of the IP, studystart dates, required wash-out dates, is the IP a biologic compound,number of days between screening and randomization, end of study, andlast visit date.

The method can further include collecting via email, fax, or any othermethod and use of screening number and randomization numbers given bythe CRO, site, or sponsor clinical trial (such as but not limited byIVRS/IWRS) to update study status as participants move from in screeningto randomization and study completion as it applies to protectionsagainst all of the protocol violations and duplicate enrollment.

The system 10 can be used to make warning lists or “hold lists” by theresearch site or clinical pharmacology unit to prevent poor qualitysubjects from entering in to more of their trials. This list willautomatically warn the user at the time of verification.

The system 10 can report subjects that are in screening periods morethan 30 days or are “dual screeners” attempting to screen at more thanone site at a time.

The system 10 can send out automatic notices to the research site if asubject in screening or enrolled at their site is attempting to screensomewhere else. The site has the ability to update the subject's statusdirectly from this email with a link to the Verified Clinical Trialssite.

The system 10 can run reports on all types of protocol violations andstatus's of the research subjects. The system has a built in dosingcalendar to send out reminders on which day dosing will occur.

There are several advantages of the present invention. The uniqueidentifier code is reproducible and can catch minor variations of theinformation in cases of different forms of identification being used tocreate the unique identifier code or when there is human error with dataentry. The method and system can be used for all phases of studies inall types of disease entities for drug and device trials. The method andsystem can detect and prevent many types of protocol violationsdescribed above that previously have taken too much time or thatcompanies previously have not had enough participant information todetect. This improves clinical trial safety for the potentialparticipant thereby reducing adverse events and serious adverse events.It also promotes improved clinical trial data to the Sponsor andultimately the consumer. The process reduces placebo events and therebysaves the pharmaceutical sponsor money.

Also, because of HIPAA compliance, the only human that can legally touchthe data collected in the database server 14 is the research sitepersonnel that is observing and taking measurements for a currentclinical trial. During a new trial, when the screen is run to check theprospective participant's eligibility, the humans running the screen canonly receive a “yes” or “no” answer for the eligibility, under HIPAAcompliance they are not allowed to know the reason why they are inviolation of protocol. The prospective participant's consent obtained atthe beginning of the method is critical because it allows the system tolook at their personal information.

The invention is further described in detail by reference to thefollowing experimental examples. These examples are provided for thepurpose of illustration only, and are not intended to be limiting unlessotherwise specified. Thus, the invention should in no way be construedas being limited to the following examples, but rather, should beconstrued to encompass any and all variations which become evident as aresult of the teaching provided herein.

EXAMPLE 1

FIGS. 2-4 show more detailed steps in the method of screeningparticipants for the clinical trials. Each of these steps can bemodified as necessary for a particular trial. TABLE 1 below summarizesthe various steps of inputs, outputs, and rules violated. Failure Rulesand Warning Rules are also summarized below.

In the first step (1), it must be determined whether the patientcredentials match deleted UIC's within the system. If there is a match,it is checked whether the data was entered 30 days or more. If 30 dayshave passed, the same UIC can be assigned to the participant and theycan be entered in the trial. If it has been less than 30 days, there isa verification failure and the participant should not be entered in thetrial.

If the patient credentials did not match deleted UIC's, a complete matchis checked for at (2). If there is a complete match, and if theparticipant is in Screening or Randomized, there is a verificationfailure. Once a patient signs a study specific consent, they enter thescreening period. In this period a series of tests are performed to seeif they are eligible and meet the criteria to proceed with the study andreceive the medication or treatment offered in the protocol.Randomization is the process of administering treatment, which caninclude placebo. At this point they are monitored for efficacy and anyadverse events. Once a participant signs consent and is “in screening”they can no longer screen for or participate in another clinical trialuntil they either early terminate or complete the study and for at least30 days thereafter. If the participant is not in Screening orRandomized, and ET or Completed is the case, a check is made for 30 dayspassing ET means early terminate for various reasons. This can be foradverse events or side effects, lack of efficacy, or competing medicalissues, or simply if the subject withdraws their consent and no longerwishes to participate. Completed means they finished all planned visitsof the study and will be eligible for any other study at least 30 daysor more later. If less than 30 days have passed, there is a verificationfailure, but if 30 days or more have passed, the participant can beentered into the trial.

If there was not a complete match at (2), a check is made for completeID and (Date of Birth (DOB) or Last Name) matches at (3) (see FIG. 3 ).There are several cases that could match: ID and Last Name, ID and DOB,or ID, DOB, and Last Name. If there is a match at (3), the status ischecked for the participant being in Screening or Randomized, and ifthey are, there is a verification failure. If they are not, and ET orCompleted is the case, a check is made for 30 days passing. If less than30 days have passed, there is a verification failure, but if 30 days ormore have passed, the participant can be entered into the trial.

If a match was not made at (3), a check is made for 4 or more ExactMatches (excluding gender), such as First Name (FN), Last Name (LN),Middle Name (MN), and DOB at (4). If a match is found, the steps areperformed the same as if a match is found at (3).

If a match is not found at (4), then a check is made for a match of LastName, Gender, DOB, First Initial, and Middle Initial at (5) (see FIG. 4). If there is a match, the status is checked for the participant beingin Screening or Randomized, and if they are, there is a Warning. AWarning means that there are many identifiers in the information thatare not an exact match of the UIC. For instance, if there is atypographical error and a wrong birthdate is put in to the system, or ifthe name is not entered exactly then an amber colored warning banner canappear on the screen. It states that there are many portions ofinformation that very closely resemble a subject already in the databaseand to please make sure there are no errors. The study coordinator orindividual entering the data can make the choice if this indeed not amatch or is a match and thereby resulting in a Verification Success orpass, or Verification Failure. If the participant is not in Screening orRandomized, and ET or Completed is the case, a check is made for 30 dayspassing. If less than 30 days have passed, there is a Warning, but if 30days or more have passed, the participant can be entered into the trial.

If a match is not found at (5), then a check is made for a match ofMiddle Name, Last Name, and DOB at (6). If there is a match, the stepsare performed the same as if a match is found at (5).

If there is not a match at (6), a check is made for a match of PartialString of First Name, exact Last Name, and Gender at (7). If there is amatch, the steps are performed the same as if a match is found at (5).

If there is not a match at (7), a check is made for a match of ID onlybeing a complete match at (8). If there is a match, the steps areperformed the same as if a match is found at (5).

If there is not a match at (8), a check is made for a match of 5consecutive digits of the ID, exact First Name, exact Last Name, and DOBat (9). If there is a match, the steps are performed the same as if amatch is found at (5). If there is not a match, then the participant canbe entered into the trial.

TABLE 1 Sr. Rule No Input Output Violated 1 Complete Id AND DOB Failure#3 2 Complete Id AND Last Name Failure #3 3 Complete Id AND First NameWarning Not tracked by any Rule 4 Complete Id AND Middle Name WarningNot tracked by any Rule 5 Complete Id AND Gender Warning Not tracked byany Rule 6 Complete Id AND Initials Warning Not tracked by any Rule 7First Name, Last Name, Middle Name Failure #4 and DOB 8 First letter ofFirst Name, First Letter Warning #5 of Middle Name, complete Last Name,Gender AND DOB 9 Complete Middle Name, Complete Warning #6 Last Name ANDDOB 10 First 3 letters of First Name, complete Warning #7 Last Name,Gender AND DOB 11 Only ID Number completely Matches Warning #8 12 5consecutive digits in ID, complete Warning #9 First Name, Complete LastName AND DOB 13 5 consecutive digits in ID AND First Pass Initial 14 5consecutive digits in ID AND Pass Complete First Name 15 5 consecutivedigits in ID AND Pass Complete Last Name 16 5 consecutive digits in IDAND Pass Complete Middle Name 17 5 consecutive digits in ID AND PassGender 18 5 consecutive digits in ID AND DOB Pass 19 First Initial,Complete Middle, Pass Complete Last AND Gender 20 All Credentials notmatching Pass 21 First Initial, middle initial, last initial Pass andDOB 22 First Initial, middle initial, last initial Pass and gender

Failure Rules:

Rule 1: If UIC matches with a deleted Subject, Then check if the 30 dayshave been past its deletion, If yes then PASS, otherwise FAILURE

Rule 2: All Credentials Complete Match

Rule 3: [Complete ID and DOB] OR [Complete ID and Last Name]

Rule 4: 4 or More Exact Match excluding Gender.

Warning Rules:

Rule 5: First Initial and Middle Initial and exact Last name and Genderand DOB

Rule 6: exact Middle Name and exact Last Name and DOB

Rule 7: Partial string matches in First Name and exact Last Name andGender and DOB

Rule 8: Complete ID Only

Rule 9: 5 consecutive digits in ID and exact First Name and exact LastName and DOB

EXAMPLE 2

The following is an example of an algorithm used to encrypt and decryptdata.

Throughout this application, various publications, including UnitedStates patents, are referenced by author and year and patents by number.Full citations for the publications are listed below. The disclosures ofthese publications and patents in their entireties are herebyincorporated by reference into this application in order to more fullydescribe the state of the art to which this invention pertains.

The invention has been described in an illustrative manner, and it is tobe understood that the terminology, which has been used is intended tobe in the nature of words of description rather than of limitation.

Obviously, many modifications and variations of the present inventionare possible in light of the above teachings. It is, therefore, to beunderstood that within the scope of the appended claims, the inventioncan be practiced otherwise than as specifically described.

What is claimed is:
 1. A method of screening participants for a clinicaltrial, including the steps of: obtaining identifying information from aprospective participant chosen from the group consisting of a biometricsample, personal information, physical attributes, and combinationsthereof; populating a database server with the identifying participantinformation and storing the information on non-transitory computerreadable media; accessing a screening mechanism in electroniccommunication with the database server and screening the participant forthe clinical trial based on the participant information and thescreening mechanism searching for a match with existing participantinformation in the database server and a plurality of outside databasesto determine protocol violations, wherein the outside databases includeeach of clinical trial databases, IVRS/IWRS databases, screening/dosinglogs, clinical trial management systems (CTMS), databanks that haveresearch subject information, databanks that have information regardingdrug/medication use, blood product donation databases, sperm banks, andhuman by-product databases, and wherein the protocol violations includeeach of the prospective participant currently being in-screening at thesame or another research site, the prospective participant violating therequired number of half lives since the last research trial, theprospective participant violating the washout period in between trials,the prospective participant violating a biologic modifier washoutperiod, the prospective participant exposed to the same investigationalcompound if exclusionary per the protocol, the prospective participanthas exceeded the maximum number of clinical trials per period of time,the prospective participant already was a screen failure for the sametrial if exclusionary, the prospective participant has a blood drawviolation, the prospective participant has a plasma draw violation, andthe last visit of the prospective participant is in violation ofprotocol; electronically alerting a research site or clinical trialadministration if the participant is found to have matching informationto existing participant information in the database server or outsidedatabases based on the screening mechanism, wherein electronicallyalerting comprises determining if the participant is enrolling in theclinical trial multiple times, enrolling in multiple clinical trials atonce, enrolling in the clinical trial sooner than a specified mandatorywashout period between the clinical trials, or if any of the protocolviolations occur; and determining eligibility of the participant for theclinical trial and preventing the protocol violations.
 2. The method ofclaim 1, wherein the identifying information is a biometric samplechosen from the group consisting of hair, saliva, urine, blood, plasma,iris scan, photograph or facial recognition, a voice recording,fingerprints, and palm vein scans and combinations thereof.
 3. Themethod of claim 1, wherein the identifying information is personalinformation chosen from the group consisting of first name, middle name,last name, date of birth, gender, government issued identification, andcombinations thereof.
 4. The method of claim 3, further including, aftersaid obtaining step, the step of obtaining government issuedidentification and assuring that the participant is responsible fortaxes incurred for stipend disbursements.
 5. The method of claim 3,further including, after said obtaining step, the step of obtaining andvalidating government issued identification for criminal backgrounds andsex offender status.
 6. The method of claim 1, wherein the identifyinginformation is physical attributes chosen from the group consisting ofheight, weight, hair color, eye color, facial recognition, andcombinations thereof.
 7. The method of claim 1, wherein the participantinformation is chosen from the group consisting of history ofparticipation in other clinical trials, status of current enrollment orprospective enrollment in clinical trials, the study start and end datesof the other clinical trials, the sponsor and sponsor information forthe other clinical trials, the trial site, contact person, protocolidentifier, study number, and combinations thereof.
 8. The method ofclaim 1, wherein said screening step further includes the step ofentering the participant into the clinical trial if no matching existingparticipant information is found.
 9. The method of claim 8, furtherincluding the step of the system sending reminders to participantsregarding upcoming visits for the clinical trial.
 10. The method ofclaim 1, further including the step of generating reports frominformation in the database server.
 11. The method of claim 1, furtherincluding the step of the participant receiving a communication chosenfrom the group consisting of safety communications, new study relatedinstructions, recruitment for new studies, data or study results withregards to dose and efficacy of the investigational treatment,engagement of the participant, and combinations thereof.
 12. The methodof claim 1, wherein said obtaining step utilizes a system chosen fromthe group consisting of an IVRS (interactive voice response system) andan IWRS (interactive web response system).
 13. The method of claim 1,further including the step of notifying research site and verifiedclinical trial administration if prospective participants are determinedto be violating protocol.
 14. The method of claim 1, wherein saidscreening step further includes accessing and pulling all data andunifying the data in the database server and the outside databases toperform said screening step.
 15. The method of claim 1, furtherincluding, after said obtaining step, the steps of generating a uniqueidentifier code, populating the database server with the uniqueidentifier code, and screening the participant for the clinical trialbased on the unique identifier code.
 16. A system for screeningparticipants for a clinical trial, comprising: an electronic databaseserver in electronic communication with a server instance for collectingparticipant information on non-transitory computer readable media, saidserver instance including a screening mechanism for determiningeligibility of the participant for the clinical trial and preventingprotocol violations and being in electronic communication with aplurality of outside databases including each of clinical trialdatabases, IVRS/IWRS databases, screening/dosing logs, clinical trialmanagement systems (CTMS), databanks that have research subjectinformation, databanks that have information regarding drug/medicationuse, blood product donation databases, sperm banks, and human by-productdatabases, wherein said protocol violations include each of theprospective participant currently being in-screening at the same oranother research site, the prospective participant violating therequired number of half lives since the last research trial, theprospective participant violating the washout period in between trials,the prospective participant violating a biologic modifier washoutperiod, the prospective participant exposed to the same investigationalcompound if exclusionary per the protocol, the prospective participanthas exceeded the maximum number of clinical trials per period of time,the prospective participant already was a screen failure for the sametrial if exclusionary, the prospective participant has a blood drawviolation, the prospective participant has a plasma draw violation, andthe last visit of the prospective participant is in violation ofprotocol, and said server instance including an alerting mechanism forelectronically alerting a research site or clinical trial administrationif the participant is found to have matching information to existingparticipant information in said electronic database server or outsidedatabases based on said screening mechanism, wherein said alertingmechanism determines if the participant is enrolling in the clinicaltrial multiple times, enrolling in multiple clinical trials at once,enrolling in the clinical trial sooner than a specified mandatorywashout period between the clinical trials, or if any of the protocolviolations occur, and said system determining eligibility of theparticipant for the clinical trial and preventing the protocolviolations.
 17. The system of claim 16, further including a uniqueidentifier code generator, a report generating mechanism and acommunication mechanism for communicating with trial participants, andwherein said electronic database collects unique identifier codesgenerated.